Last reviewed 2026-04-20 · How we verify

MORPHINE SULFATE

Morphine Sulfate is a marketed drug primarily indicated for acute pain management, holding a significant position in the analgesic market. The key composition patent is set to expire in 2028, providing a period of exclusivity that supports current market dominance. The primary risk is the potential increase in competition following the patent expiry in 2028.

At a glance

Approved indications

• Acute Pain Management
• Chronic Pain Management

Boxed warnings

• WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of morphine sulfate tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of morphine sulfate tablets are essential [see Warnings and Precautions ( 5.2 )]. Accidental Ingestion Accidental ingestion of even one dose of morphine sulfate tablets, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions ( 5.2 )] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of morphine sulfate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )]. Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions ( 5.4 )]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions ( 5.5 )]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE TABLETS See full prescribing information for complete boxed warning. Morphine sulfate tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and regularly evaluate for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of morphine sulfate tablets are essential. ( 5.2 ) Accidental ingestion of morphine sulfate tablets, especially by children, can result in a fatal overdose of morphine. ( 5.2 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.3 , 7 ) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.4 ) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription. ( 5.5 )

Common side effects

• Constipation
• Nausea
• Sedation
• Dizziness
• Vomiting
• Sweating
• Dysphoria
• Euphoric mood
• Tachycardia
• Bradycardia
• Palpitations
• Visual impairment

Serious adverse events

• Respiratory depression
• Apnea
• Respiratory arrest
• Circulatory depression
• Hypotension
• Shock
• Serotonin syndrome
• Adrenal insufficiency
• Anaphylaxis
• Addiction, Abuse, and Misuse

Drug interactions

• Benzodiazepines and Other Central Nervous System (CNS) Depressants
• Serotonergic Drugs
• Monoamine Oxidase Inhibitors (MAOIs)
• Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
• Muscle Relaxants

Key clinical trials

• Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
• Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (PHASE3)
• Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine (PHASE3)
• Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (PHASE2)
• Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion (EARLY_PHASE1)
• Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum (NA)
• Analgesic Effects of Intrathecal Morphine and Transversalis Plane Block After Cesarean Delivery
• Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• MORPHINE SULFATE CI brief — competitive landscape report
• MORPHINE SULFATE updates RSS · CI watch RSS